P001 An audit to assess whether patients who had a delayed or missed denosumab dose during the covid-19 pandemic came to any harm or suffered a subsequent fracture

Abstract

Abstract Background/Aims Denosumab is licensed by NICE for the secondary prevention of osteoporosis in patients who are unable to comply, have an intolerance, or contraindication to bisphosphonates. With the outbreak of Covid-19, denosumab appointments were delayed. A delay of denosumab doses by more than 16 weeks is associated with an increased risk of vertebral fractures. This audit was carried out to see if the Pandemic caused a delayed (>1 month) or missed (>6 months) dose in patients receiving their denosumab injection and whether this delay/missed dose resulted in patients coming to any harm such as a subsequent fracture. Methods We included 166 patients of which 95% were female. We stratified data utilising the Oberoi consulting clinical audit services which provided a database of patients who were on six monthly repeat prescriptions for Denosumab. Retrospective data was collected including indications for denosumab, start date, duration, missed or delayed doses, reasons for delayed doses and whether a fracture of a pathological nature was sustained. We later reviewed if the missed or delayed doses occurred during the covid pandemic (2020-22) and subsequently, if the fracture occurred as a result of the pandemic. Results 34/166(21%) patients did not receive their Denosumab dose on time during Covid-19. 21/166(12.6%) patients had a delayed dose (6 pre-Covid and 15 post-Covid) and 13/166 (7.8%) patients missed a dose entirely (3 pre-Covid and 10 post-Covid) showing more delays/missed doses occurred during the pandemic. Reasons as to why patients did not receive timely doses include, clinical reasons (7/34 20.6%), patient safety decisions made by clinicians in patients’ best interest 12/34(35.3%) and patient choice related factors 15/34 (44.1%). Reasons for delays include not wanting repeat bloods, being on holiday, chest infection low Vitamin D levels, pre dose bloods delayed, patient had covid, and isolating. Whilst on Denosumab, 8/166(4.8%) patients sustained a fracture of which 6/8(75%) also experienced a delayed/missed dose during Covid-19. Conclusion Of the 34/166 patients that had a delayed/missed dose, eight suffered a fracture bringing the fracture risk to 23.5% which is an increase from baseline (6.6%) confirming that a missed Denosumab dose does increase fracture risk. We can conclude a greater proportion of patients endured a missed or delayed dose as a consequence of the Covid-19 pandemic. 8/166(4.8%) patients sustained a fracture of which six had a missed/delayed dose as a result of the pandemic. The conclusions drawn are in keeping with the MHRA4 alert, a missed dose of Denosumab does increase the risk of pathological treatment discontinuation fractures. This highlights to clinicians the significance of timely doses and uninterrupted treatment. Disclosure S. Rehman: None. S. Sultan: None.